Accurett
Accurett (S-ACT-10) is a general cryosurgical system (FDA Class II; FDA product code GEH, Unit, Cryosurgical, Accessories) made by H & O Equipments SA, cleared under FDA 510(k) K161615 on 23 Aug 2016 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B386SACT100), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB386SACT100 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161615 | Date23 Aug 2016 | StatusActive |
Official records
- FDA 510(k) database K161615
Across registries
- FDA 510(k) K161615 decided 23 Aug 2016 Active
- FDA GUDID UDI-DI B386SACT100 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K161615
- Listed FDA GUDID B386SACT100
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- General cryosurgical system, cryogen gas, mechanical
- Model / Ref / Catalog
- Accurett, S-ACT-10
- Primary DI / UDI-DI
- B386SACT100
- 510(k) Number
- FDA product code
- GEH
- GMDN term
- General cryosurgical system, cryogen gas, mechanical
- Device class
- Class II
- Regulation number
- 878.4350
- GUDID distribution status
- In Commercial Distribution
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